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NCT01393119 · ClinicalTrials.gov registry record · Phase 2
Phase II, Dose Finding Study of GTx-758
A Phase 2 study, sponsored by GTx.
- Terminated
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT01393119: Clinical Trial Phase 2 study, sponsored by GTx.
NCT01393119 is a Phase 2 study that was terminated before completion, run by GTx. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393119, a Phase 2 study, was terminated before completion, sponsored by GTx.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.
Primary Outcome
Percentage of Patients Note: Due to the study being terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only. PLEASE NOTE: Study was terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, the efficacy summary provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only, p
Interventions
- DRUG GTx-758
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01393119 stopped before completion
NCT01393119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which GTx-758 is the first listed.
NCT01393119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01393119 about?
NCT01393119 is a clinical study titled "Phase II, Dose Finding Study of GTx-758". The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.
What is the current status of trial NCT01393119?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2011-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01393119?
The interventions under investigation include: GTx-758 (DRUG).
Who is sponsoring clinical trial NCT01393119?
This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01393119's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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